Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with no secondary cause of bone loss. In the course of our prior research with premenopausal women with IOP, the investigators have shown that women with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to normal women. Additionally, using noninvasive high resolution imaging of the central and peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the investigators identified several features of bone quality in premenopausal women with IOP.
There is currently no FDAapproved therapy for IOP in premenopausal women. However, teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis. Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of about 113,000 in the United States, pharmaceutical companies are unlikely to support development of therapies for this indication. Therefore the major objective of this protocol is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a randomly selected group of patients (10) will receive one year of placebo injections first before starting their two years of treatment. The remainder of subjects (30) will receive active drug only for two years.
Adult Idiopathic Generalized Osteoporosis
Drug: Saline Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women|
- Change in lumbar spine bone mineral density (LS-BMD) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Teriparatide (Forteo)
Daily injection of Teriparatide for treatment of idiopathic osteoporosis
Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
Other Name: Forteo
Placebo Comparator: Placebo saline injection
Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.
Drug: Saline Placebo
Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440803
|Contact: Mariana Bucovsky, BAemail@example.com|
|Contact: Adi Cohen, MDfirstname.lastname@example.org|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator: Robert Recker, MD|
|Sub-Investigator: Joan Lappe, MD|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator: Elizabeth Shane, MD|
|Sub-Investigator: Adi Cohen, MD|
|Sub-Investigator: Emily M Stein, MD|
|Principal Investigator:||Elizabeth Shane, MD||Columbia University|
|Study Director:||Adi Cohen, MD||Columbia University|
|Study Director:||Emily M Stein, MD||Columbia University|